Background: The novel Navitor intra-annular self-expandable transcatheter aortic valve prosthesis is designed to improve coronary access, reduce paravalvular leaks, and enhance hemodynamic performance. Comparative data with the established Evolut platform (R, Pro, FX) are still lacking. This study aimed to evaluate the short-term clinical outcomes of Navitor (NAV) versus Evolut transcatheter heart valves. Methods: We conducted a single-center analysis of patients undergoing transfemoral TAVR between January 2015 and May 2024. A propensity score matching protocol including 18 baseline variables was used to balance baseline characteristics. Clinical outcomes were assessed using VARC-3 criteria. Results: Of 1067 TAVR patients, 210 were analyzed after matching—70 with the Nav valve and 140 with the Evolut valve. Baseline characteristics were comparable between groups, with a mean age of 80.9 ± 6.5 years in the NAV group and 80.7 ± 6.7 years in the Evolut group (p = 0.9). Both groups had an intermediate STS predicted risk of mortality, 3.9 ± 3.4% for NAV and 3.9 ± 3.2% for Evolut (p = 1.0). The effective aortic annulus diameter was comparable between the NAV (23.9 ± 1.5 mm) and Evolut group (23.9 ± 2.4 mm, p = 0.8). Hemodynamic performance at discharge was similar, with mean gradients of 7.5 ± 2.8 mmHg (NAV) vs. 7.4 ± 3.7 mmHg (Evolut, p = 0.9). Valve orifice areas and paravalvular leak rates showed no difference between the groups. Device success rates at discharge were good for both THVs: 89.3% for Evolut and 91.4% for NAV (p = 0.8). Disabling stroke occurred less frequently in the NAV group (0.0% vs. 7.1%, p = 0.033), while other early safety outcomes and 30-day mortalities were similar. Conclusions: The Navitor valve offers comparable hemodynamic performance, paravalvular leak rates, and procedural success to the Evolut platform. While early safety outcomes were largely similar, the Navitor valve was associated with a lower 30-day disabling stroke rate.

Background: Recently, the use of surgically implanted aortic bioprostheses has been favoured in younger patients. We aimed to analyse the long-term survival and postoperative MACCE (Major Adverse Cardiovascular and Cerebral Event) rates in patients after isolated aortic valve replacement. Methods: We conducted a single-centre observational retrospective study, including all consecutive patients with isolated aortic valve replacement. 1:1 propensity score matching of the preoperative baseline characteristics was performed. Results: A total of 2172 patients were enrolled in the study. After propensity score matching the study included 428 patients: 214 biological vs. 214 mechanical prostheses, divided into two subgroups: group A < 60 years and group B > 60 years. The mean follow-up time was 7.6 ± 3.9 years. Estimated survival was 97 ± 1.9% and 89 ± 3.4% at 10 years for biological and mechanical prosthesis, respectively in group A (p = 0.06). In group B the survival at 10 years was 79.1 ± 5.8% and 69.8 ± 4.4% for biological and mechanical prosthesis, respectively (p = 0.83). In group A, patients with a bioprosthesis exhibited a tendency for higher cumulative incidence MACCE rates compared to patients with a mechanical prosthesis, p = 0.83 (bio 7.3 ± 5.3% vs. mech 4.6 ± 2.2% at 10 years). In group B, patients with a mechanical prosthesis showed a tendency for higher cumulative incidence MACCE rates compared to patients with bioprosthesis, p = 0.86 (bio 4.3 ± 3.1% vs. mech 9.1 ± 3.1% at 10 years). Conclusions: Long-term survival after surgical aortic valve replacement is similar in patients with a biological and mechanical prosthesis, independent of the patients’ age. Moreover, younger patients (<60 years) with bioprosthesis showed a survival benefit, compared to patients with mechanical prosthesis in this age group.

Introduction Acute kidney injury (AKI) is a common complication after cardiac surgery (CS) and is associated with adverse short-term and long-term outcomes. Alpha-1-microglobulin (A1M) is a circulating glycoprotein with antioxidant, heme binding and mitochondrial-protective mechanisms. RMC-035 is a modified, more soluble, variant of A1M and has been proposed as a novel targeted therapeutic protein to prevent CS-associated AKI (CS-AKI). RMC-035 was considered safe and generally well tolerated when evaluated in four clinical phase 1 studies. Methods and analysis This is a phase 2, randomised, double-blind, adaptive design, parallel group clinical study that evaluates RMC-035 compared with placebo in approximately 268 cardiac surgical patients at high risk for CS-AKI. RMC-035 is administered as an intravenous infusion. In total, five doses will be given. Dosing is based on presurgery estimated glomerular filtration rate (eGFR), and will be either 1.3 or 0.65 mg/kg. The primary study objective is to evaluate whether RMC-035 reduces the incidence of postoperative AKI, and key secondary objectives are to evaluate whether RMC-035 improves postoperative renal function compared with placebo. A blinded interim analysis with potential sample size reassessment is planned once 134 randomised subjects have completed dosing. An independent data monitoring committee will evaluate safety and efficacy data at prespecified intervals throughout the trial. The study is a global multicentre study at approximately 30 sites. Ethics and dissemination The trial was approved by the joint ethics committee of the physician chamber Westfalen-Lippe and the University of Münster (code ‘2021-778 f-A’) and subsequently approved by the responsible ethics committees/relevant institutional review boards for the participating sites. The study is conducted in accordance with Good Clinical Practice, the Declaration of Helsinki and other applicable regulations. Results of this study will be published in a peer-reviewed scientific journal. Trial registration number NCT05126303.

Background/Objectives: In the presence of porcelain aorta (PA), transcatheter aortic valve replacement (TAVR) has become a class I therapeutic indication for the treatment of severe aortic valve stenosis. To date, few studies have analyzed the clinical outcomes of TAVR in PA patients. We aim to analyze the calcification patterns of the thoracic aorta in PA patients and to evaluate their clinical implications for TAVR procedures. Methods: This study included 161 patients who had PA confirmed through pre-operative CT and underwent TAVR between 11/2014 and 12/2022. The primary outcome was to perform a multi-slice CT (MSCT) analysis assessing the calcification in the proximal, middle, and distal thoracic aortic segments. Each segment was divided into quadrants for scoring calcifications on a scale from 1 (75%). The cohort was categorized into circular or noncircular calcification group. The secondary clinical outcomes were defined according to VARC-3 criteria. Results: The study cohort included 161 patients (median age, 77.2 years; IQR, 70.1–82.6 years). The median EuroSCORE II and STS predicted risk of mortality were 3.10% [1.80–5.58] and 2.70% [1.70–4.30], respectively. In 75% of patients (n = 121/161), TAVR was performed via transfemoral access. Circular calcifications were found in 8.1% of patients, while noncircular calcifications were present in 91.9%. Significant calcifications were primarily in the right quadrant of the proximal segment (33.54%), superior quadrant of the middle segment (39.75%), and left quadrant of the distal segment (73.29%). The 30-day mortality rate was 3.11% and periprocedural ischemic stroke rate 3.38%. Conclusions: Most TAVR patients with PA exhibited noncircular calcification. The most extensive calcifications were primarily in areas relevant to surgical manipulation. Patients with PA displayed low short-term mortality and relatively few stroke events. In view of these findings, TAVR constitutes a valid treatment option for patients with PA and aortic stenosis.

Background: The study aims to compare the short-term clinical outcomes of transcatheter aortic valve implantation (TAVI) with the novel self-expandable, intra-annular Navitor valve (NAV) and the balloon-expandable, intra-annular Sapien 3 Ultra valve (S3U). Methods: From a single-center TAVI database, patients receiving NAV and S3U were identified. We applied 1:2 propensity score matching for the selected variables (gender, age, aortic valve perimeter, area, diameter, mean aortic valve gradient, EuroScore2, coronary artery disease (CAD), previous stroke and previous pacemaker implantation), resulting in 153 patients. Results: Clinical outcomes at 30 days of 51 patients with NAV [mean age: 80.4 ± 6.7 years; 51% female; mean annulus diameter: 24.1 ± 1.40 mm; EuroScore2: 3.4 ± 3.1%] and 102 patients with S3U [mean age: 79.9 ± 6.5 years (p = 0.7); 51% female (p > 0.99); mean annulus diameter: 24.1 ± 1.4 mm (p > 0.99); EuroScore2: 3.2 ± 2.7 (p = 0.7)] were analyzed according to VARC-3 recommendations. Post-TAVI aortic valve mean (S3U: 11.0 [3–27] mmHg; NAV: 7 [3–15] mmHg; p < 0.001) and maximum (S3U: 22 [6–44] mmHg; NAV: 12 [5–28] mmHg; p < 0.001) gradients at discharge were significantly lower with NAV, whereas the effective orifice area (EOA) of the aortic valve measured significantly larger with NAV (S3U: 1.5 [0.8–3.8] cm²; NAV: 2.1 [0.9–3.5] cm²; p < 0.001). Rates of no to mild paravalvular regurgitation (PVL) were 92.1% after NAV and 91.2% after S3U implantation (p = 0.15), mild to moderate PVL were 2.0% after NAV vs. 2.9% after S3U (p = 0.1) and moderate PVL were 2% after NAV and 1% after S3U (p = 0.07). None of the patients had a severe regurgitation. Severe patient–prosthesis mismatch (PPM) occurred significantly less with NAV (S3U: 14.7%; NAV: 7.8%; p = 0.002). One (1%) non-disabling stroke occurred within the S3U group and none occurred within the NAV group (p = 0.1). Life-threatening (S3U: 2.9%; NAV= 1%; p > 0.99) and major (S3U: n = 2.9; NAV: 0%; p = 0.55) bleeding events were comparable between both groups. The incidence of major (S3U: 2.9%; NAV: 2.0%; p > 0.99) vascular complications and the need for permanent pacemaker implantation (S3U: 9.8%; NAV: 11.8%; p = 0.8) were comparable in both groups. The 30-day mortality rate was 0.7% [1 in NAV group (2%), none in S3U; p = 0.3]. Conclusions: In conclusion, at 30-day follow-up, the self-expanding intra-annular Navitor valve demonstrated excellent acute safety and superior early hemodynamic performance, characterized by significantly lower transvalvular gradients and lower rates of severe PPM compared to the balloon-expandable Sapien 3 Ultra. However, whether these acute hemodynamic advantages translate into superior long-term clinical outcomes remains to be determined in long-term follow-up studies.